Morphine After Radiofrequency Ablation of Painful Bone Metastases in Patients With Cancer

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-24

Study Completion Date

2016-03-16

Brief Summary

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RATIONALE: Morphine may reduce pain in patients who have undergone radiofrequency ablation to remove bone metastases.

PURPOSE: This phase II trial is studying how well morphine works after radiofrequency ablation of painful bone metastases in patients with cancer.

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Detailed Description

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OBJECTIVES:

Primary

* Measure the efficacy of morphine sulfate at 8 weeks after radiofrequency ablation (RFA) of bone metastases.

Secondary

* Assess minimum and average pain and analyze use of morphine sulfate before and after RFA.
* Determine disease progression by CT scan of bone.
* Evaluate the percentage of relief associated with RFA, specifically patient satisfaction, quality of life, anxiety, depression, and physical performance during RFA.
* Assess complications and side effects related to RFA and the evolution of possible side effects associated with morphine sulfate therapy.

OUTLINE: This is a multicenter study.

Patients complete a pain questionnaire over 1 week before undergoing radiofrequency ablation (RFA). Patients also complete questionnaires about pain, physical performance, quality of life (QOL), and anxiety at baseline.

Bone metastases are removed by radiofrequency ablation (RFA). After surgery, patients receive acetaminophen and patient-controlled analgesic (PCA) morphine sulfate. PCA morphine sulfate continues with a dose increase of 50% bolus every 24 hours. Patients with maximum pain less than or equal to that at inclusion receive standard morphine sulfate therapy instead.

Data concerning the total dose of PCA morphine sulfate; minimum, average, and maximum pain intensity; side effects and complications of RFA; and total dose of morphine sulfate (or equivalent) is collected daily.

Pain is assessed at 4 and 8 weeks after RFA. Patients complete follow-up questionnaires about physical performance, QOL, and anxiety at 12 weeks. Patients also undergo a CT scan at 12 weeks.

Conditions

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Metastatic Cancer Pain Unspecified Adult Solid Tumor, Protocol Specific

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Patient who has undergone radiofrequency ablation of bone metastases

Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.

Group Type EXPERIMENTAL

Acetaminophen

Intervention Type DRUG

Intravenous administration of paracetamol (4 g / 24h) and patient-controlled analgesia (PCA).

Morphine Sulfate

Intervention Type DRUG

Patient-controlled analgesia (PCA), allowing morphine consumption to be titrated to the patient's needs and thus allowing morphine doses to be adapted to an increase in pain in the patient's post-operative period or a rapid analgesic effect of radiofrequency.

Questionnaire administration

Intervention Type OTHER

Pain notebook will allow the patient to describe the pain specific to the metastasis concerned, containing information on :

* The intensity of the minimum, average and maximum pain of the last 24 months. hours as well as the intensity of the pain of the moment according to a scale 11-point digital,
* the background morphine analgesic treatment during the last 24 hours,
* the morphine analgesic treatment taken during painful attacks,
* the possible undesirable effects of morphine treatment.
* the morphinic, non-morphinic and co-antalgic treatment is noted, as well as that the total dose of oral morphine or oral morphine equivalent

Quality-of-life assessment

Intervention Type PROCEDURE

Patients' quality of life will be assessed using the quality of life questionnaire EORTC QLQ-C30 at inclusion in the study and at 8 weeks after radiofrequency. ablation.

Radiofrequency ablation

Intervention Type PROCEDURE

Recent technique of thermal destruction of tumors.

This technique consists of inserting an electrode needle into the tumour under X-ray or ultrasound guidance or intraoperatively under laparoscopy for example. This needle carries a current or a light wave depending on the characteristics of the generator to which it is connected (radiofrequency, laser).

Radio frequencies are radiation non-ionising electromagnets. In this context of tissue ablathermia wavelengths ranging from 400kHz to 500kHz.

Interventions

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Acetaminophen

Intravenous administration of paracetamol (4 g / 24h) and patient-controlled analgesia (PCA).

Intervention Type DRUG

Morphine Sulfate

Patient-controlled analgesia (PCA), allowing morphine consumption to be titrated to the patient's needs and thus allowing morphine doses to be adapted to an increase in pain in the patient's post-operative period or a rapid analgesic effect of radiofrequency.

Intervention Type DRUG

Questionnaire administration

Pain notebook will allow the patient to describe the pain specific to the metastasis concerned, containing information on :

* The intensity of the minimum, average and maximum pain of the last 24 months. hours as well as the intensity of the pain of the moment according to a scale 11-point digital,
* the background morphine analgesic treatment during the last 24 hours,
* the morphine analgesic treatment taken during painful attacks,
* the possible undesirable effects of morphine treatment.
* the morphinic, non-morphinic and co-antalgic treatment is noted, as well as that the total dose of oral morphine or oral morphine equivalent

Intervention Type OTHER

Quality-of-life assessment

Patients' quality of life will be assessed using the quality of life questionnaire EORTC QLQ-C30 at inclusion in the study and at 8 weeks after radiofrequency. ablation.

Intervention Type PROCEDURE

Radiofrequency ablation

Recent technique of thermal destruction of tumors.

This technique consists of inserting an electrode needle into the tumour under X-ray or ultrasound guidance or intraoperatively under laparoscopy for example. This needle carries a current or a light wave depending on the characteristics of the generator to which it is connected (radiofrequency, laser).

Radio frequencies are radiation non-ionising electromagnets. In this context of tissue ablathermia wavelengths ranging from 400kHz to 500kHz.

Intervention Type PROCEDURE

Other Intervention Names

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Paracetamol Oral morphine equivalent

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Histologically confirmed cancer

* Primary or unknown origin
* Painful bone metastases despite radiotherapy or symptomatic relapse into previously irradiated area with no possibility of repeating radiotherapy

* Bone metastases may have been treated with bisphosphonates
* Osteolytic bone or joint (lytic and condensed) confirmed by CT scan and meeting the following criteria:

* Lesion size ≤ 5 cm
* No more than 2 painful bone metastases

* If 2 lesions are to be treated, distinct anatomical locations can be treated at the same time
* Metastatic bone lesions of the pelvis, sacrum (in absence of canal involvement), ribs, or long bones allowed
* Pain located at the tumor or in the area
* Maximum pain in the last 24 hours \> 4 points (numerical scale to 11 points)

PATIENT CHARACTERISTICS:

* Life expectancy \> 3 months
* Platelet count \> 50,000/μL
* Prothrombin \< 50%
* Activated cephalin time ≤ 1.5 times normal
* Not pregnant
* Fertile patients must use effective contraception
* No geographical, social, or psychiatric reason that would preclude follow up

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* At least 4 weeks since prior radiotherapy
* At least 3 weeks since prior chemotherapy or bisphosphonates
* At least 1 week since beginning new painkiller therapy or anticoagulation treatment
* More than 30 days since participation in another drug study
* More than 30 days since prior surgery

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No